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19 April, 2024 16:10 IST
Lupin receives tentative USFDA approval for generic Tadalafil tablets
Source: IRIS | 19 Jul, 2018, 11.34AM
Rating: NAN / 5 stars.
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Pharma major Lupin announced that it has received tentative approval for its Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and company's Galls Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.

Lupin's Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg is the generic version of Eli Lilly and company's Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. It is indicated for the treatment of erectile dysfunction; the signs and symptoms of benign prostatic hyperplasia; erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.

Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg had annual sales of approximately USD 1949.2 million in the US (IQVIA MAT April 2018).

Shares of the company declined Rs 2.3, or 0.28%, to trade at Rs 807.50. The total volume of shares traded was 393,452 at the BSE (11.21 a.m., Thursday).

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